AccessGUDID - DEVICE: THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM (00690103210866)

GUDID

Device Identifier (DI) Information

Brand Name: THE EDWARDS SAPIEN 3 VALVE WITH ALTERRA ADAPTIVE PRESTENT SYSTEM
Version or Model: 29AP4045
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 29AP4045A
Company Name: Edwards Lifesciences LLC

Primary DI Number: 00690103210866
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 134139174 *Terms of Use

Device Description: ALTERRA ADAPTIVE PRESTENT SYSTEM (US) 40MM X 48MM

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
60247	Pulmonary transcatheter heart valve bioprosthesis	An implantable xenograft (e.g., bovine, porcine) intended to be used to repair/replace a stenosed or regurgitant pulmonary heart valve prosthesis (previously implanted), or native pulmonary valve anatomy that may have been surgically repaired, and which is designed to be implanted with a catheter via vascular access. It may be attached to an expandable metal framework which may be expanded with a balloon or self-expand, and may include other material types (e.g., synthetic polymer). Devices associated with implantation (e.g., catheter, introducer) may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NPV	Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200015	011

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3241c6d4-749c-45b7-94dd-d6c60fe5fb68
Public Version Date: December 31, 2021
Public Version Number: 1
DI Record Publish Date: December 23, 2021